Ignite Creation Date:
2025-12-24 @ 1:03 PM
Ignite Modification Date:
2025-12-26 @ 6:09 PM
Study NCT ID:
NCT06294561
Status:
COMPLETED
Last Update Posted:
2024-06-27
First Post:
2024-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TGRX-326 Pharmacokinetic Drug Interaction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-05-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-26', 'studyFirstSubmitDate': '2024-02-28', 'studyFirstSubmitQcDate': '2024-02-28', 'lastUpdatePostDateStruct': {'date': '2024-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma Tmax', 'timeFrame': 'Itraconazole group: Day 1, Days 2-6, Day 11, Days 12-15 and Day 16 (or last day of dosing); Efavirenz group: Day 1, Days 2-6, Day 20, Day 21-24 and Day 25 (or last day of dosing)', 'description': 'Time to maximum concentration of TGRX-326 measured in plasma'}, {'measure': 'Plasma Cmax', 'timeFrame': 'Itraconazole group: Day 1, Days 2-6, Day 11, Days 12-15 and Day 16 (or last day of dosing); Efavirenz group: Day 1, Days 2-6, Day 20, Day 21-24 and Day 25 (or last day of dosing)', 'description': 'Maximum concentration of TGRX-326 measured in plasma'}, {'measure': 'Plasma AUC(0-t)', 'timeFrame': 'Itraconazole group: Day 1, Days 2-6, Day 11, Days 12-15 and Day 16 (or last day of dosing); Efavirenz group: Day 1, Days 2-6, Day 20, Day 21-24 and Day 25 (or last day of dosing)', 'description': 'Area Under drug concentration-time curve (AUC) from time 0 to last measureable timepoint for TGRX-326 as measured in plasma'}, {'measure': 'Plasma AUC(0-inf)', 'timeFrame': 'Itraconazole group: Day 1, Days 2-6, Day 11, Days 12-15 and Day 16 (or last day of dosing); Efavirenz group: Day 1, Days 2-6, Day 20, Day 21-24 and Day 25 (or last day of dosing)', 'description': 'Area Under drug concentration-time curve from time 0 to infinity for TGRX-326 as measured in plasma'}, {'measure': 'T1/2', 'timeFrame': 'Itraconazole group: Day 1, Days 2-6, Day 11, Days 12-15 and Day 16 (or last day of dosing); Efavirenz group: Day 1, Days 2-6, Day 20, Day 21-24 and Day 25 (or last day of dosing)', 'description': 'Plasma half-life of TGRX-326'}, {'measure': 'Plasma volume of distribution (Vz/F)', 'timeFrame': 'Itraconazole group: Day 1, Days 2-6, Day 11, Days 12-15 and Day 16 (or last day of dosing); Efavirenz group: Day 1, Days 2-6, Day 20, Day 21-24 and Day 25 (or last day of dosing)', 'description': 'Apparent volume of distribution of TGRX-326 in plasma'}, {'measure': 'Plasma clearance (CL/F)', 'timeFrame': 'Itraconazole group: Day 1, Days 2-6, Day 11, Days 12-15 and Day 16 (or last day of dosing); Efavirenz group: Day 1, Days 2-6, Day 20, Day 21-24 and Day 25 (or last day of dosing)', 'description': 'Apparent clearance of TGRX-326 in plasma'}], 'secondaryOutcomes': [{'measure': 'Adverse events/serious adverse events', 'timeFrame': 'through completion of the study, an average of 1 month', 'description': 'to record and analyse subjects with adverse events (AEs) and serious adverse events (SAEs)'}, {'measure': 'Corrected QT Interval', 'timeFrame': 'At screening; Itraconazole group: Day 1, Days 2-5, Day 11, Days 12-15 and Day 16 (or last day of dosing); Efavirenz group: Day 1, Day 20 and Day 25 (or last day of dosing)', 'description': 'Corrected QT Interval (QTc) as measured by 12-lead electrocardiogram'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'This is a drug-drug interaction study for TGRX-326 to evaluate the effects of CYP3A inhibitor/inducer drugs on pharmacokinetic profiles of TGRX-326, an ALK inhibitor indicated for treatment of Non-small cell lung cancer.', 'detailedDescription': 'This study is designed as an open-label, single sequence, self-controlled study. The study will be conducted for 2 cycles, 10 days per cycle. Itraconazole, a CYP3A inhibitor, and Efavirenz, a CYP3A inducer, will be administrated orally with TGRX-326 to evaluate the effect of these drugs on the pharmacokinetic profiles of TGRX-326. Pharmacokinetic parameters will be evaluated as primary endpoints. Safety evaluation will also be conducted.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy subject; male or female\n* Age between 18 and 45 (inclusive)\n* body mass index (BMI) between 19.0 and 26.0 (inclusive)\n* agree to consent\n* able to communicate with investigator well and complete the study according to study protocol\n\nExclusion Criteria:\n\n* abnormal and clinically significant test results (including physical exam, laboratory tests, 12-lead ECG, chest x-ray, etc.)\n* any one positive result for hepatitis-B surface antigen, Hepatitis C antibody, HIV antibody or syphilis antibody\n* prolongation in QT interval\n* use of substance that affects CYP3A4 enzyme activity with 30 days before screening\n* use of any drug within 14 days of test article administration\n* use of any investigational drug or participation of any clinical study within 3 months before screening\n* vaccination within 14 days before first test article administration, or have plans to receive vaccination during the study period\n* history of cardiovascular diseases\n* history of mental conditions including depression, aggressive behaviours, epilepsy, etc.\n* history of major surgery within 6 months before screen, or have unhealed surgical wounds.\n* any clinically significant conditions that investigator believes could affect study outcomes\n* history of allergic reactions, or allergic to any components to the study drugs, or have food allergy/special requirement for food that forbids the subject to follow food requirements for the study\n* daily cigarette consumption of more than 5 within 3 months before screening, or cannot avoid using cigarette/tabacco products during the study\n* history of alcohol abuse (more than 14 units of alcohol per week) within 3 months before screening, or alcohol breath test of \\> 0.0 mg/dl at screening\n* history of substance abuse, or positive drug results at screening\n* history of certain food intake 2 weeks before screening, and/or use of more than 8 cups of tea/coffee/grapefruit juice\n* positive pregnancy test results, or pregnant/breast-feeding females\n* history of unprotected sexual activities within 1 month before screening\n* have plans for child bearing during study period and for 6 months after study, or disagree to take contraceptive measures during study period and for 6 months after study\n* history of blood donation or blood loss within 3 months before screening, or have plans to donate blood within 1 month after the study\n* any reasons that is deemed unsuitable for study participation as determined by investigator'}, 'identificationModule': {'nctId': 'NCT06294561', 'briefTitle': 'TGRX-326 Pharmacokinetic Drug Interaction', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shenzhen TargetRx, Inc.'}, 'officialTitle': 'An Open-label, Two-cycle, Single Sequence, Self-controlled Study Evaluating Effects of Oral Itraconazole or Efavirenz on Pharmacokinetic Profiles of TGRX-326', 'orgStudyIdInfo': {'id': 'TGRX-326-1003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Itraconazole', 'description': 'healthy subjects will be given Itraconazole 200 mg orally with TGRX-326 60 mg', 'interventionNames': ['Drug: Itraconazole+TGRX-326']}, {'type': 'EXPERIMENTAL', 'label': 'Efavirenz', 'description': 'healthy subjects will be given Efavirenz 600 mg orally with TGRX-326 60 mg', 'interventionNames': ['Drug: Efavirenz+TGRX-326']}], 'interventions': [{'name': 'Itraconazole+TGRX-326', 'type': 'DRUG', 'description': 'healthy subjects will be given TGRX-326 60 mg orally on Day 1, and Itraconazole 200 mg with TGRX-326 60 mg orally on day 11', 'armGroupLabels': ['Itraconazole']}, {'name': 'Efavirenz+TGRX-326', 'type': 'DRUG', 'description': 'healthy subjects will be given TGRX-326 60 mg orally on Day 1, and Efavirenz 600 mg with TGRX-326 60 mg orally on day 20', 'armGroupLabels': ['Efavirenz']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210008', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Nanjing Drug Tower Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'overallOfficials': [{'name': 'Juan Li, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nanjing Drug Tower Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shenzhen TargetRx, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}